REDWOOD CITY, Calif., Feb 28, 2022 (GLOBE NEWSWIRE via COMTEX) --
RAS(ON) Inhibitor Pipeline Continues to Advance and Expand, Now Addressing Majority of RAS-Addicted Cancers; Two New Drug Candidates Recently Nominated
Recently Announced First Patient Dosed in Global Phase 2 Study Evaluating Combination of RMC-4630 and Lumakras(TM) (sotorasib) in Patients with Advanced Non-Small Cell Lung Cancer
mTORC1-Selective Inhibitor, RMC-5552, Demonstrates Preliminary Evidence of Clinical Activity in Ongoing Phase 1/1b Monotherapy Study
REDWOOD CITY, Calif., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. /zigman2/quotes/216320743/composite RVMD +1.61% , a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers, today announced its financial results for the fourth quarter and year ended December 31, 2021 and provided a corporate update.
"Revolution Medicines continues to advance our integrated RAS-focused pipeline consisting of innovative RAS(ON) Inhibitors and RAS Companion Inhibitors. RMC-6236, a RAS [MULTI] (ON) inhibitor, and RMC-6291, a KRAS [G12C] (ON)-selective inhibitor, are both on track to enter the clinic this year. In addition, we recently reported the addition of two new oral, covalent, mutant-selective RAS(ON) inhibitors to our development-stage pipeline. RMC-9805 is a selective inhibitor of KRAS [G12D] (ON), and RMC-8839 is a selective inhibitor of KRAS [G13C] (ON), neither target of which is served today by targeted drugs," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines.
"Our RAS Companion Inhibitor pipeline also continues to mature. We disclosed that a first patient has been dosed in RMC-4630-03, our global Phase 2 study of RMC-4630 in combination with sotorasib in patients with non-small cell lung cancer carrying a KRAS [G12C] mutation. In addition, in the dose escalation phase of our Phase 1/1b clinical trial of RMC-5552, our selective inhibitor of mTORC1, we reported preliminary evidence of clinical activity against advanced tumors with mutations associated with hyperactive mTORC1 signaling. We look forward to advancing each of these promising programs in 2022 toward our goal to serve substantial unmet needs among patients with RAS-addicted cancers."
RAS(ON) Inhibitors - Revolution Medicines continues to build on its innovative RAS(ON) Inhibitor platform, producing an expansive collection of tri-complex inhibitors targeting diverse oncogenic RAS variants through highly differentiated chemical and pharmacologic profiles.
RMC-6236 (RAS [MULTI] ) - RMC-6236 is a first-in-class, potent, oral RAS-selective tri-complex, RAS [MULTI] (ON) inhibitor designed to treat cancers driven by a variety of KRAS mutations, including those that can emerge following treatment with KRAS [G12C] (OFF) inhibitors.
RMC-6291 (KRAS [G12C] ) - RMC-6291 is a first-in-class, potent, oral and selective tri-complex inhibitor of KRAS [G12C] (ON) with a differentiated preclinical profile designed to serve patients with cancers driven by KRAS [G12C] .
RMC-9805(KRAS [G12D] ) - RMC-9805 is an oral, mutant-selective, covalent inhibitor of KRAS [G12D] (ON) which is the primary tumor driver in more than 50,000 new patients primarily with colorectal, pancreatic or lung cancer annually in the United States.
RMC-8839 (KRAS [G13C] ) - RMC-8839 is an oral, mutant-selective, covalent inhibitor of KRAS [G13C] (ON) that Revolution Medicines believes is the first compound to directly target KRAS [G13C] , an important therapeutic target primarily for lung cancer and select CRC patients who are not currently served by any targeted RAS drug.
Continued expansion of other RAS(ON) Inhibitor programs - Revolution Medicines continues to progress its growing portfolio of orally bioavailable, mutant-selective RAS(ON) Inhibitors designed to target RAS variants driving RAS-addicted cancers that are unserved by targeted drugs.
RAS Companion Inhibitors - Revolution Medicines continues to advance and expand multiple clinical studies of its RAS Companion Inhibitors designed to provide maximum clinical benefit in RAS-addicted cancers.
RMC-4630 (SHP2 Inhibitor) - RMC-4630, a potent, oral, selective inhibitor of the SHP2 protein, is being advanced in partnership with, and is primarily funded by, Sanofi our global SHP2 development and commercialization partner.
RMC-5552 (mTORC1/4EBP1 Inhibitor) - RMC-5552 is a potent, selective bi-steric inhibitor of mTORC1 that suppresses phosphorylation and inactivation of 4EBP1.
Fourth Quarter and Full Year 2021 Financial Highlights
Cash Position:Cash, cash equivalents and marketable securities were $577.1 million as of December 31, 2021, compared to $440.7 million as of December 31, 2020. The increase was primarily due to proceeds from the company's public equity offering in February 2021.
Revenue: Total revenue, consisting of revenue from the company's collaboration agreement with Sanofi, was $9.5 million for the quarter ended December 31, 2021, compared to $8.8 million for the quarter ended December 31, 2020.
Total revenue was $29.4 million for the year ended December 31, 2021, compared to $43.0 million for the year ended December 31, 2020. During the third quarter of 2021, the company recorded a non-cash, non-recurring GAAP accounting adjustment that reduced collaboration revenue by $8.5 million as a result of a change in estimate of the accounting transaction price and percentage of completion of work performed to date under its agreement with Sanofi. The decrease in revenue in 2021 was primarily due to the non-cash revenue adjustment and lower reimbursed manufacturing costs.
R&D Expenses: Research and development expenses were $53.7 million for the quarter ended December 31, 2021, compared to $37.0 million for the quarter ended December 31, 2020. Research and development expenses were $186.9 million for the year ended December 31, 2021, compared to $132.3 million for the year ended December 31, 2020. The increases were primarily due to an increase in research expenses associated with the company's pre-clinical research portfolio, an increase in personnel-related expenses related to additional headcount, and an increase in stock-based compensation.
G&A Expenses: General and administrative expenses were $8.7 million for the quarter ended December 31, 2021, compared to $5.8 million for the quarter ended December 31, 2020. General and administrative expenses were $30.5 million for the year ended December 31, 2021, compared to $21.4 million for the year ended December 31, 2020. The increases were primarily due to an increase in stock-based compensation, an increase in personnel-related expenses related to additional headcount, and higher legal and accounting fees.
Net Loss: Net loss was $52.7 million for the quarter ended December 31, 2021, compared to net loss of $34.2 million for the quarter ended December 31, 2020. Net loss was $187.1 million for the year ended December 31, 2021, compared to net loss of $108.2 million for the year ended December 31, 2020.
2022 Financial Guidance
Revolution Medicines expects full year 2022 GAAP net loss to be between $260 million and $290 million, which includes estimated non-cash stock-based compensation expense of $35 million to $40 million.
Revolution Medicines will host a conference call and webcast this afternoon, February 28, 2022, at 4:30 PM Eastern (1:30 PM Pacific).
To listen to the conference call, please dial (833) 423-0425 or (918) 922-3069, provide conference ID: 9672794 and request the Revolution Medicines�?�conference call. To listen to the live webcast, or access the archived webcast, please visit:�?� https://ir.revmed.com/events-and-presentations . Following the live webcast, a replay will be available on the Company's website for at least 14 days.
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors in development include RMC-6236 (RAS [MULTI] ), RMC-6291(KRAS [G12C] ), RMC-9805 (KRAS [G12D] ) and RMC-8839 (KRAS [G13C] ), and a pipeline of research compounds targeting additional RAS variants. RAS Companion Inhibitors in clinical development include RMC-4630 (SHP2) and RMC-5552 (mTORC1/4EBP1).
Keytruda [(R) ] is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Lumakras(TM) (sotorasib) is a trademark of Amgen, Inc.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the company's development plans and timelines and its ability to advance its portfolio and R&D pipeline; dosing and enrollment in the company's clinical trials and the tolerability and potential efficacy of the company's candidates being studied; the ability of the company's therapies to inhibit frontier targets and to serve unmet needs in RAS-addicted cancers; the company's plans to advance the development of RMC-6291, RMC-6236, RMC-9805 and RMC-8839; the potential of RMC-9805 to be best-in-class; the company's plans to nominate a fifth development candidate from its RAS(ON) inhibitor portfolio; the timing of Amgen's disclosure of data from the CodeBreaK 101c study; and enrollment in and findings from the company's RMC-4630-03 study; the company's plans to study RMC-5552 in combination with RAS inhibitors; the expected timing of additional results from the company's Phase 1/1b clinical trial of RMC-5552; the potential advantages and effectiveness of the company's preclinical candidates, including its RAS(ON) Inhibitors; . Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company's development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company's ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company's capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on the company's business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines' Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2022, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
REVOLUTION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
Three Months Ended
|Collaboration revenue, related party||$||9,460||$||8,751||$||29,390||$||42,983|
|Research and development||53,681||37,006||186,948||132,252|
|General and administrative||8,692||5,825||30,450||21,428|
|Total operating expenses||62,373||42,831||217,398||153,680|
|Loss from operations||(52,913||)||(34,080||)||(188,008||)||(110,697||)|
|Other income, net:|
|Interest and other expense||--||(14||)||(12||)||(71||)|
|Total other income, net||237||238||917||2,167|
|Loss before income taxes||(52,676||)||(33,842||)||(187,091||)||(108,530||)|
|Benefit from (provision for) income taxes||--||(362||)||--||371|
|Redeemable convertible preferred stock dividends - undeclared and cumulative||--||--||--||(2,219||)|
|Net loss attributable to common stockholders||$||(52,676||)||$||(34,204||)||$||(187,091||)||$||(110,378||)|
|Net loss per share attributable to common stockholders - basic and diluted||$||(0.71||)||$||(0.52||)||$||(2.57||)||$||(2.01||)|
|Weighted-average common shares used to compute net loss per share, basic and diluted||73,831,121||66,319,926||72,806,079||54,874,119|
REVOLUTION MEDICINES, INC.
SELECTED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, unaudited)
|December 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||577,054||$||440,741|
|Working capital (1)||529,423||406,946|
|Total stockholders' equity||602,568||474,676|
(1) Working capital is defined as current assets less current liabilities.
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